RISK COMMUNICATION AND TRANSPARENCY

Track:
Pharmacovigilance

Day & Time:
March 6, 11:00AM - 12:30PM

Session Number:
0406

Room Number:
Elicium 2

Type:
Session

Title:
RISK COMMUNICATION AND TRANSPARENCY

Chair(s):
Jan Petracek, MD,MSc
CEO
European Pharminvent Services, Czech Republic

Description:
Feedback to healthcare professionals and public about outcomes of pharmacovigilance processes and assessments used to be a weak point in Community Pharmacovigilance system. New EU legislation enables a significant increase in transparency of regulatory authorities, sharing the results of work done by industry. This includes Safety Web Portals, central assessment of risk communication documents by the Pharmacovigilance Risk Assessment Committee (PRAC), publishing summaries of Risk Management Plans, agendas and minutes of pharmacovigilance meetings, access to data in EudraVigilance and meeting requirements of EU Good Pharmacovigilance Practice Module 15 on Safety Communication.

Presentation(s) & Speaker(s):
Role of PRAC in Transparency and Communication
Mick Foy
Group Manager
MHRA, United Kingdom

Impact of Increased Transparency on the Industry
Angelika Joos, MPharm
Executive Director, Regulatory Policy, EU and Most of World
Merck Sharp & Dohme Inc., Belgium

Determinants of impact of Drug Safety Warnings. A retrospective analysis of Direct Healthcare Professional Communications.
Peter GM Mol, PhD,RPh
assistant professor / head assessor
University Medical Center Groningen / Dutch Medicines Evaluation Board, Netherlands